This position is responsible for performing ongoing corrective, predictive, and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various classified areas up to a Class 100 aseptic environment. In addition, the role requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. The individual will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects.

• Complete emergency repair, rebuilding, changeover, and inspection work on process related equipment. Install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner

• Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs

• Responsible for equipment and system performance through data monitoring within the assigned operating area

• Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment

• Provide training to operators for equipment set-up and for minor adjustments or repairs

• Install new equipment and oversee equipment upgrades according to site SOPs

• Perform 5S activities and maintain organization of operating areas

• Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines

• Be familiar with “Material Safety Data Sheets” for area chemicals

• Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed

• Work with minimal supervision under the direction of the Maintenance Manager, Process Managers, Engineer, or other activity leads

• Perform roles of Technician and Mechanical Technician as required to support daily PET activities

• Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs

• Follow and maintain compliance with established MRO procedures and inventory control

• Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities

• Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas (Area Dependent)

• Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment

• Perform other similar and related responsibilities as assigned by area management

• Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET

Minimum Qualifications

• Prior experience in a regulated production environment, specifically responsible for equipment maintenance and performance
• Prior people leadership experience, including supervising, mentoring, or developing direct reports
• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
• Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair

Preferred Qualifications

• High school graduate, vocational school graduate, or equivalent
• Associate degree in engineering or a related discipline or equivalent mechanical trade school graduate.
• Previous experience with automated equipment
• Training in mechanics, hydraulics, electronics, and testing equipment in electrical and/or mechanical troubleshooting
• Knowledge of data and materials maintenance systems such as SAP, KRONOS, or other MRP systems
• Experience with OEE, TPM, LEAN or other Continuous Improvement systems

Work Schedule: 12 hour – 2/2/3 Nightshift D Shift

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This position may also include the following conditions: Physical and Mental Requirements, Lifting/Carrying 35 lbs., Working at Heights of 15 ft., Sitting, Standing, Walking, Bending, Stooping, Twisting, Reaching, Repetitive Motion, Noise Exposure, Operating Vehicles, Operative Moving Machinery, Chemical Usage, Traveling, Wearing Personal Protective Equipment

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.